Envarsus Xr is a drug owned by Veloxis Pharmaceuticals Inc. It is protected by 25 US drug patents filed from 2015 to 2025. Out of these, 11 drug patents are active and 14 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2028. Details of Envarsus Xr's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8664239 | Tacrolimus for improved treatment of transplant patients |
Aug, 2028
(1 year, 10 months from now) | Active |
| US8685998 | Tacrolimus for improved treatment of transplant patients |
Aug, 2028
(1 year, 10 months from now) | Active |
| US8644239 | Method and apparatus for allocating and processing sequences in communication system |
Aug, 2028
(1 year, 10 months from now) | Active |
| US11123331 | Tacrolimus for improved treatment of transplant patients |
May, 2028
(1 year, 7 months from now) | Active |
| US10166190 | Stabilized tacrolimus composition |
May, 2028
(1 year, 7 months from now) | Active |
| US12083103 | Tacrolimus for improved treatment of transplant patients |
May, 2028
(1 year, 7 months from now) | Active |
| US11419823 | Stabilized tacrolimus composition |
May, 2028
(1 year, 7 months from now) | Active |
| US9549918 | Stabilized tacrolimus composition |
May, 2028
(1 year, 7 months from now) | Active |
| US10864199 | Tacrolimus for improved treatment of transplant patients |
May, 2028
(1 year, 7 months from now) | Active |
| US12403095 | Stabilized Tacrolimus Composition |
May, 2028
(1 year, 7 months from now) | Active |
| US11110081 | Tacrolimus for improved treatment of transplant patients |
May, 2028
(1 year, 7 months from now) | Active |
| US8617599 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US7994214 | Solid dispersions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8591946 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US9757362 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8623410 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US9763920 | Solid dispersions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US10548880 | Solid dispersions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8889186 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8623411 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8889185 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8586084 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US8486993 | Solid dispersions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US9161907 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
| US11077096 | Modified release compositions comprising tacrolimus |
Aug, 2024
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Envarsus Xr's patents.
Latest Legal Activities on Envarsus Xr's Patents
Given below is the list of recent legal activities going on the following patents of Envarsus Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Feb, 2026 | US11419823 |
| Expire Patent | 09 Feb, 2026 | US8623411 |
| Expire Patent | 09 Feb, 2026 | US8623410 |
| Expire Patent | 02 Feb, 2026 | US8617599 |
| Expire Patent | 22 Dec, 2025 | US8586084 |
| Expire Patent | 27 Oct, 2025 | US9763920 |
| Expire Patent | 20 Oct, 2025 | US9757362 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Sep, 2025 | US8685998 |
| Recordation of Patent Grant Mailed | 09 Sep, 2025 | US12403095 |
| Expire Patent | 08 Sep, 2025 | US11077096 |
FDA has granted several exclusivities to Envarsus Xr. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Envarsus Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Envarsus Xr.
Exclusivity Information
Envarsus Xr holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Envarsus Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Jul 10, 2022 |
| Orphan Drug Exclusivity(ODE-94) | Jul 10, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Envarsus Xr is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Envarsus Xr's family patents as well as insights into
ongoing legal events
on those patents.
Envarsus Xr's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Envarsus Xr:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Envarsus Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 30, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Envarsus Xr Generic API suppliers:
Tacrolimus is the generic name for the brand Envarsus Xr. 18 different companies have already filed for the generic of Envarsus Xr, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Envarsus Xr's generic
How can I launch a generic of Envarsus Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Envarsus Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Envarsus Xr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Envarsus Xr -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 31 Mar, 2022 | 30 Aug, 2028 | Less |
Alternative Brands for Envarsus Xr
Envarsus Xr which is used for preventing organ rejection in transplant patients., has several other brand drugs using the same active ingredient (Tacrolimus). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Astellas |
| |
| Leo Pharma As |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tacrolimus, Envarsus Xr's active ingredient. Check the complete list of approved generic manufacturers for Envarsus Xr
About Envarsus Xr
Envarsus Xr is a drug owned by Veloxis Pharmaceuticals Inc. It is used for preventing organ rejection in transplant patients. Envarsus Xr uses Tacrolimus as an active ingredient. Envarsus Xr was launched by Veloxis in 2015.
Approval Date:
Envarsus Xr was approved by FDA for market use on 10 July, 2015.
Active Ingredient:
Envarsus Xr uses Tacrolimus as the active ingredient. Check out other Drugs and Companies using Tacrolimus ingredient
Treatment:
Envarsus Xr is used for preventing organ rejection in transplant patients.
Dosage:
Envarsus Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 0.75MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| EQ 1MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |